MRC:LISP STUDY
You are being invited to take part in a research study. You need to understand why the research is being done and what it will involve. Please take time to read this information carefully, and discuss it with others if you wish. Feel free to ask us if there is anything that is not clear, or if you would like more information. You may wish to read this information more than once, and should take time to decide whether or not you wish to take part
What is the purpose of the study?
We are studying where lithium goes to in the brain and the effects it has on pictures we get from the brain scans. Lithium is used to treat mania, a psychiatric illness in which people have high mood, energy surges and increased activity. These symptoms respond quite swiftly to lithium, and it is generally accepted that this is due to the effects of lithium on the brain. However, it is unclear how much of a given dose of lithium reaches the brain, and which parts of the brain are most affected by its actions.
Why have I been given this information?
We are looking for about ten volunteers to take part in our study. Volunteers should be fit and healthy without a history of psychiatric illness. It is also important that volunteers do not drink alcohol or smoke to excess. If you fit these criteria, we would like to invite you to enter our study.
Do I have to take part?
No. As entry to the study is entirely voluntary, it is up to you to decide whether or not to take part. You should not feel under any pressure to make the decision. If you do decide to take part, you will be asked to sign a consent form but you are still free to withdraw at any time and without giving a reason. This will not affect any care you may receive in the future.
What will happen to me if I take part?
You will be invited to come to Newcastle Magnetic Resonance Centre to discuss the study in more detail. Here we will explain what we are doing, our reasons for conducting this study and answer any questions you may have. If you want to get involved we will set up some appointments for you to attend. These will all be within working hours, most probably in the morning.
What is the nature of the research?
Lithium is used in the treatment of mania and the dose is checked by testing the level of lithium in the blood. We know very little about the relationship between blood levels and brain levels. This is because physically sampling the brain to measure lithium is not something we, or our patients would want to do. However, developments technology have allowed us to ‘re-tune’ our brain scanner to detect lithium. We can now measure the concentration and distribution of lithium in the human brain in a safe manner. We want to compare brain and blood levels of lithium in normal volunteers to validate the test and to build up a reference range for future work with patients.
We also plan to investigate the effects of lithium on brain water. In manic depression (bipolar disorder), the movement of water in the cells of the brain is different to normal people and that this may link to the altered brain function. Lithium may correct these abnormalities. As part of the scan sessions, we will use the magnetic resonance scanner to assess how freely water moves in and out of cells before and after lithium. Again, this is a simple and safe scan to perform.
What will this study involve?
The initial assessment
You will be asked to come to Newcastle Magnetic Resonance Centre for a routine assessment where we will conduct a series of questionnaires designed to exclude mental illness and symptoms of depression or mania (assessments performed by Dr David Cousins). We will do a brief external physical examination and some blood tests to make sure that it's safe to go ahead with the study. This should take no more than an hour.
The next stage
If you are suitable to take part in the study, we will ask you to have a brain scan. This will take about 30 minutes to complete, during which time you simply have to lie down in the scanner. During this scan we will look at the structure of your brain and the behaviour of water in the brain cells. The scanner is like a tube, and some people find it a little claustrophobic. If you know that you suffer from claustrophobia then you should not volunteer for this study. It is also quite noisy, though generally not unpleasant and you can listen to the radio or some music if you like. If you do become uncomfortable you can let us know and we will stop the scan immediately.
Lithium prescription
We need subjects to take lithium for one week at the correct dose before we can repeat the brain scan. Lithium takes a short while to get into your body and reach the correct level, and this level can be checked with a blood test. We will give you a starting dose based on your age, weight and blood tests, and ask you to return after five days treatment for a blood test. If that blood test is ok, you will be asked to keep taking that dose for about seven days before coming back. If the blood level is not spot-on, the dose will be changes and checked again. When the correct dose is reached, you will continue at that dose for seven days until rescanning. We usually get the dose correct on the first attempt.
Repeat Scans
At the end of the treatment period, the sbrain scan will be repeated. In this second session we will measure the levels of lithium in you brain using a new piece of equipment. This will take an extra 30 minutes, so the second scan will last about 1 hour.
What are the effects of Lithium?
The dose of lithium we are using in this study has been proven to be safe in previous studies. You may have some mild side effects such as sickliness or tiredness. If you develop side effects such as tremor, excess sleep or thirst, you should contact us or your family doctor. We will give you a list of things to look out for and instructions if problems arise.
What are the advantages of taking part?
Your participation is unlikely to benefit you directly. It is hoped that the information that this study provides will help us the understand more about the nature of mania and its treatments. You will get to see you brain however!
Will I be paid?
No, but we will compensate you for your travel and time. We are currently offering a flat rate reimbursement of £50 for this study.
What if something goes wrong?
If you are harmed by taking part in this research project, there are no special compensation arrangements to cover non-negligent injury. If you are harmed due to someone’s negligence, then you may have grounds for a legal action but you may have to pay for it. Regardless of this, if you wish to complain, or have any concerns about any aspect of the way you have been approached or treated during the course of this study, you should approach NewcastleUniversity for advice.
Will my participation be confidential?
Yes. We will hold some personal information on file at the Newcastle University. Your personal details will not be routinely available to the researchers as all forms will be completed using an anonymised personalised identification number. Only the university staff directly involved with the research will have access to your details.
We are obliged to inform your GP about your participation in the research, and will ask your permission before we do so.
What will happen to the results of the research?
After the study is completed, we will analyse the results and submit them for publication in a scientific journal. Presentations may also be given at scientific conferences. You will not be identified in any publication or presentation. If you wish to know the outcome of our research, we will be happy to discuss them with you.
Who is organising the research?
The principal investigator is Dr David Cousins from the Newcastle Magnetic Resonance Centre. The research is publicly funded by a grant from the Medical Research Council and is under the supervision of Professors Andrew Blamire and Nicol Ferrier.
What should I do now?
If you are interested in taking part in our study, then you should contact the research team and we can advise you further on how to proceed. If you have any questions about the project, or wish to meet the team prior to reaching your decision, we would be happy to this with you.
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